NCT05398679

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis

Detailed description

The trial will include patients diagnosed with left-side Infective Endocarditis according to the modified Duke criteria, with ≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery The patients will be randomized in two arms, one with oral antibiotic therapy and the other one with outpatient parenteral therapy This trial aims to demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT), to improve the quality of life of infective endocarditis (IE) patients, and to reduce the cost of the intervention without increasing morbidity and mortality rates

Conditions

• Endocarditis Infective

Interventions

Type	Name	Description
DRUG	Cefaclor	cefaclor intravenous 2 gr/day
DRUG	Ciprofloxacin Tablets	500-750 mg/12 hrs (maximum 3g x day)
DRUG	Ciprofloxacin Injection	1200 mg/day maximum dose IV
DRUG	Clindamycin Oral Capsule	600 mg/8 hours (maximum 1.800 mg x day)
DRUG	Clindamycin Injection	600 mg/8 hours (maximum 1.800 mg x day) IV
DRUG	Dicloxacillin Oral Capsule	1g/8 hours (maximum 4 gr day)
DRUG	Dicloxacillin	1g/8 hours (maximum 4 g x day) IV
DRUG	Fusidic Acid Only Product in Oral Dose Form	0,750g/12 hours (maximum 1,5 g x day)
DRUG	Fusidic Acid Only Product in Parenteral Dose Form	0,75 g/12 hours (maximum 1,5 g x day)
DRUG	Levofloxacin Oral Tablet	0.5g/12-24hours (maximum 1 g x day)
DRUG	Levofloxacin Injection	0.5g/12-24hours (maximum 1 g x day)
DRUG	Linezolid Oral Tablet	0,6 g/12 hours (maximum 1200 mg x day)
DRUG	Linezolid Injectable Product	0,6 g/12 hours (maximum 1200 mg x day)
DRUG	Moxifloxacin tablet	0,4 g/day (maximum 400 mg x day)
DRUG	Moxifloxacin Injectable Product	0,4 g/day (maximum 400 mg x day)
DRUG	Rifampicin Only Product in Oral Dose Form	0,3-0,5 g/12 hours (maximum 1200 mg x day)
DRUG	Rifampicin Only Product in Parenteral Dose Form	0,3-0,6 g/12 hours (maximum 1200 mg x day)
DRUG	Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]	sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
DRUG	Sulfamethoxazole / Trimethoprim Injectable Product	sulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
DRUG	Tedizolid Oral Tablet	200 mg tedizolid (maximum x day)
DRUG	Tedizolid Injection	200 mg (maximum x day)
DRUG	Amoxicillin Capsules	1 gr/6 hours (4 g x day)
DRUG	Amoxicillin	1 gr/6 hours (4 g x day) Intravenous
DRUG	Cefaclor Capsules	2 gr/day

Timeline

• Start date: 2022-08-17
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2022-06-01
• Last updated: 2026-02-25

Locations

20 sites across 1 country: Spain